Houses

If you are planning to submit an SBIR/STTR proposal to the National Institutes of Health (NIH) before the August 5 deadline, one of your first considerations should be which of its many Institutes/Centers (IC) will be a fit for your project.

The NIH is an umbrella organization with 27 Institutes/Centers within its purview. Even though you submit a single SBIR/STTR application to NIH, your application is typically “housed” in one of the ICs after funding decisions are made. The program managers at each of the ICs are able to provide some feedback on the fit between your SBIR/STTR project and the IC. So here are two BBC tips to get you started.

BIOSTL

Four new Entrepreneurs In Residence (EIRs) have joined the BioGenerator, a nonprofit subsidiary of BioSTL, to create, lead, and support new bioscience companies St. Louis. The EIRs will work with existing start-up companies across the region to further their growth and with researchers and entrepreneurs to launch new enterprises.

In just the last two years, BioGenerator’s new programs for pre-seed funding (Spark Fund and i6 Project) and shared laboratory facilities (Accelerator Labs), along with its historical seed funding program, have supported the creation of 17 new bioscience companies in St. Louis, validating the rich supply of bioscience innovation locally. These new EIRs will help to advance the growth of existing companies and assist in the creation of additional regional startups.

tesaro-logo

Tesaro, a biotech focused on the treatment of chemotherapy-induced symptoms, announced terms for its IPO on Tuesday. The Waltham, MA-based company plans to raise $81 million by offering 6.0 million shares at a price range of $12 to $15. At the midpoint of the proposed range, Tesaro would command a market value of $360 million.

The company's lead product candidate, rolapitant, is in Phase 3 trials, the results of which are expected in the 2H13. No revenue has been generated to date. Venture capital firms New Enterprise Associates, InterWest Partners and Kleiner Perkins will hold 39%, 10% and 7% post-IPO stakes, respectively. Certain undisclosed insiders have expressed an interest in purchasing approximately $25 million of stock in connection with the offering.

Bio Park MD Video

Each year, the University of Maryland business development team looks forward to spending three days in early summer at arguably the most significant annual event for the life sciences industry: the BIO International Convention. Held this year in Boston, the convention brings together industry executives with corporate and academic scientists in an ideal forum for networking and marketing within the biotech industry.

The audience is ideal for the work of the university, the BioPark and the state. One of our primary objectives as attendees and exhibitors is to market the pipeline of UM bioscience technologies available for licensing. Over the course of the convention, one-on-one partnering sessions will allow our tech transfer team to conduct as many as 20 key meetings to market therapeutics; vaccines; drug targets in oncology, neurodegenerative disorders, autoimmune disorders, infectious disease; and devices. We’ll also engage with existing bioscience and pharma partners to promote and expand funding of research and clinical trial contracts with UM’s bioscience faculty and clinicians. Our final focus will be marketing the BioPark as an ideal location for bioscience companies and promoting the Park’s existing base of nearly two dozen bioscience companies. Several existing tenant companies, including Paragon Biosciences, SNBL, Vigilant Bioservices, Gliknik and Ablitech will join us at the show.

DHHS

Health and Human Services Secretary Kathleen Sebelius on Friday announced the recipients of 81 new Health Care Innovation Awards made possible by Affordable Care Act. The awards will support innovative projects nationwide designed to deliver high-quality medical care, enhance the health care workforce, and save money.

Combined with the 26 awards announced last month, HHS has distributed money to 107 projects that plan  to save the healthcare system an estimated $1.9 billion over the next three years.?

DHHS

The recipients of 81 new Health Care Innovation Awards were announced last week by U.S. Department of Health and Human Services Secretary Kathleen Sebelius.

The Health Care Innovation Awards program, created through the Affordable Care Act, is setting out to fund projects that test new payment and service delivery models while delivering high-quality care and lowering costs.

Combined with the 26 awards announced last month, HHS has distributed money to 107 projects that plan to save the healthcare system an estimated $1.9 billion over the next three years.

investmaryland.png

The Maryland Venture Fund Authority along with the Maryland Department of Business and Economic Development (DBED) hosted a free public forum on InvestMaryland - a state sponsored initiative to invest in the Maryland's start-up and early stage companies. The forum, held on the Johns Hopkins University Rockville campus, drew more than 200 entrepreneurs, venture capitalists and other stakeholders for presentations led by the Venture Fund Authority and DBED on the implementation plan for the program, as well as how to apply for funding and other State funding resources.

"There is a tremendous amount of excitement and interest by entrepreneurs as well as the venture capital community in InvestMaryland, which has the potential to create thousands of jobs over the next 10 years and position our State as a leader in science, security, health, discovery and information technology," said DBED Secretary Christian S. Johansson. "As we get ready to make our first investments, it was critical to host this Forum to educate and inform our stakeholders on how they can benefit from what is the largest venture capital investment in our State's history."

6th street commerce

6th Street Commerce, an innovative E-commerce solutions provider to the retail industry, today announced that the company was selected Maryland Incubator Company of the Year Award for the Information Technology category the evening of June 14, 2012.

Sponsored by The Maryland Technology Development Corporation (TEDCO), RSM McGladrey, Maryland Department of Business & Economic Development (Maryland DBED), and Saul Ewing LLP, the 2012 Maryland Incubator Company of the Year Awards are chosen in several categories by a selection committee of regional industry leaders and early-stage investors. The finalists for the 2012 ICOY Awards come from all over the state and represent a diverse cross-section of technologies and services. Award recipients benefit from publicity and gain greater credibility in the business, technology, and investment communities.

emergent biosolutions

Emergent BioSolutions, the Rockville biotech that sells the only approved anthrax vaccine to the federal government, has won a $220 million grant to establish a new biodefense development and manufacturing center in Maryland.

The Center for Innovation in Advanced Development and Manufacturing is designed to develop a range of medical countermeasures to biological, radiological and nuclear threats. It also will ensure the capability to produce vaccines for pandemic influenza and provide work force development programs for federal needs, according to a company statement.

Maryland

Maryland bioscience executives, along with county and state officials, are in Boston this week to sell the state’s potential to the world’s biotech industry.

With more than 15,000 expected at this year’s Biotechnology Industry Organization International Convention, which started Monday and runs through Friday, the state wants to make a strong showing through its Bio Maryland 2012 pavillion. Last year’s convention was staged in Washington, D.C.

bio-internation-convention

On the last full day of the BIO Convention, Tom Watkins, President and CEO of Human Genome Sciences and Chairman of the Board for BIO, reviewed the major policy advocacy activities of BIO over the past year at the Keynote luncheon session.

BIO has advocated for expedited approval of biosimilars in the passage of the Biosimilars User Fees act (BsUFA), and has been working to ensure policy changes that enhance transparency and help minimize review times FDA approvals are included in the fifth renewal of the Prescription Drug User Fee Act (PDUFA) which is anticipated to pass later this year.

Rich Bendis

BioHealth Innovation, Inc. (BHI), a regional private-public partnership focusing on commercializing market-relevant biohealth innovations and increasing access to early-stage funding in Central Maryland, announced today that its Board of Directors has named former Interim CEO Richard Bendis as the organization's first President & Chief Executive Officer.

Scott Carmer, BioHealth Innovation, Inc. Chairman of the Board and Executive Vice President of Commercial Operations at MedImmune, said, "The Board unanimously supported the appointment of Rich Bendis as BHI's President and CEO. As the interim CEO, Rich has been instrumental in establishing BHI, securing significant private and public sector support and funding, and developing and executing on long- and short-term strategic goals. Rich possesses unique knowledge and experience that will allow him to continue BHI's tremendous momentum to accelerate biohealth commercialization opportunities for Central Maryland."

bio-internation-convention

The Montgomery County Department of Economic Development will host a press event highlighting the nation’s first local biotech investment incentive program, initiated by Montgomery County government, the role local biotech entrepreneurs, many from County-based federal labs like NIH and FDA, play in the success of the sector and a new, regional, industry-sector led intermediary created to bolster technology transfer into commercial success during the BIO International Convention in Boston.

WHEN: Tuesday, June 19, 2012 from 3:00-4:30pm EDT.

WHERE: The Boston Convention and Exhibition Center, MA - Maryland Pavilion

WHAT: Press event featuring: MedImmune CEO Peter Greenleaf discussing the growth and success of that company in Montgomery County and that company’s leading role in supporting the newly formed BioHealth Innovation, Inc. (BHI) - an industry-lead biotech intermediary; Human Genome Sciences CEO Tom Watkins discussing the growth and success of that company in Montgomery County and the supportive local government and innovative initiatives and policies that support the sector; Montgomery County Executive Isiah Leggett discussing the success of the County’s local biotech investment incentive program and BHI Board Chair Scott Carmer, Executive Vice President, Commercial Operations for MedImmune and BHI CEO Rich Bendis discussing the early initiatives and successes of that new regional entity in bolstering the success of the region’s biotech sector.

human-genome-sciences

Biotech drugmaker Human Genome Sciences Inc. is giving all bidders until July 16 to submit their final buyout offers and appealed to GlaxoSmithKline PLC to participate even though its prior bid was rejected.

The Rockville, Md.-based company said Friday that it is committed to exploring its strategic options.

Human Genome rejected the British pharmaceutical giant's $13 per share offer last month, saying it was inadequate. At that time the company also adopted a "poison pill" shareholder rights plan in order to ward off any unsolicited takeover bids.

Serial entrepreneur panel small

A panel of entrepreneurs told the Maryland Economic Development Commission on Tuesday that Maryland needs to commercialize more discoveries made in academic and government labs and improve the entrepreneurial culture if the state hopes to compete with traditional hubs of innovation.

“You ain’t gonna replicate Silicon Valley and Boston in many places around the world. What Maryland has is unrivaled research assets that, basically, most states cannot compete with,” said Rich Bendis, interim CEO of BioHealth Innovation Inc. “The difference is, we’re talking about culture. It’s the entrepreneurial culture that’s different in those other cities.”

Bendis said Maryland’s stature is improving in the eyes of entrepreneurs and those tasked with supporting startups.

University System of Maryland

The University System of Maryland is about to adopt a new policy to formally give credit in tenure and promotion decisions for faculty work that leads to patents and other intellectual property applied in technology transfer.

The new policy, slated for final Board of Regents approval on June 23, is part of the system's broader push to promote the commercialization of academic research.

Maryland institutions receive a lot of research money but have been "very run of the mill" when it comes to transforming that research into useful products and services, said William E. (Brit) Kirwan, chancellor of the system, in an interview on Wednesday. "The culture of commercializing intellectual property just hasn't existed in Maryland."

Md bio enterprise

In response to the declining state of science education in America, MdBio Foundation, Inc. today announced it will provide science teachers and students nationwide with an innovative and immersive educational video game platform free of charge beginning in 2013. The online platform, called MdBioSphere(TM), seeks to advance student comprehension in science, technology, engineering and math (STEM) and revitalize student interest in science-related careers through the use of innovative gaming technology. The serious game is being developed by Hunt Valley, Md.-based BreakAway, Ltd., and will be previewed at the BIO International Convention (June 18-21, 2012, Booth 0753 in the Maryland Pavilion) in Boston.

"The Foundation believes that creating a globally-competitive U.S. workforce begins in the classroom," said J.J. Finkelstein, chairman of the MdBio Foundation. "The MdBioSphere platform, which will be the first serious game platform to be mapped to the new U.S. science education standards, can be a breakthrough application that helps inspire the next generation of scientists that America needs if we are to compete in the 21st century. The MdBioSphere platform merges the captivating elements of online gaming with educationally-driven STEM curricula to deliver an exciting classroom experience that enriches both students and teachers."

Greenleaf Peter05-cx250

Maryland officials are preparing to dole out the first investments of the $84 million InvestMaryland program this summer, but they must first whittle down a list of 37 venture capital firm applicants to about half a dozen.

The funding will essentially make the state a limited partner in five to eight VC firms, which will be tasked with routing the funds back into Maryland tech and biotech startups in a traditional VC role. A list of recommended firms is due to be released later this month.

NCATS

NCATS at the NIH has released two RFAs on Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3).  Applications are due on December 17, 2012.  

The National Center for Advancing Translational Sciences (NCATS) seeks to develop a therapeutics discovery pilot program that will explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program will match Agents and associated data from pharmaceutical company partners with the best ideas for new therapeutic uses from the biomedical research community.

UMD President Loh Asia

University of Maryland President Wallace Loh is extending his Asia strategy with an innovation tour of Taiwan and South Korea. In his third trip to the region, Loh is laying the groundwork for new research and educational partnerships through sessions with high-level government, industry and academic officials.

Follow Loh's live blog from Asia: http://ter.ps/vt

"Science and education transcend borders," Loh says. "A premier innovation and entrepreneurship university needs to operate in a global context today if it is to serve the state and the nation. By building new research collaborations, bringing Asian companies to our international incubator, and fostering intercontinental student exchanges, we keep Maryland plugged into the economic and intellectual currents."

DHHS

The Department of Health and Human Services has named Brian Sivak as the department’s next chief technology officer, according to Federal News Radio.

Sivak, currently chief innovation officer for Maryland Governor Martin O’Malley and the former chief technology officer for the District of Columbia, will join HHS next month and also serve as tech entrepreneur-in-residence.

PhaseBio

PhaseBio Pharmaceuticals Inc., a clinical-stage biotechnology company developing drugs to treat diabetes, metabolic disease and cardiovascular disease, has closed its Series B round with a total of $48.4 million, the company announced. The round closed after a third tranche.

PhaseBio is backed by New Enterprise Associates, Astellas Venture Management, Johnson & Johnson Development Corp., Hatteras Venture Partners and Fletcher Spaght Ventures.

angel-capital-assoc

Raise your hand if you realized the Midwest has become a hotbed of angel group activity -- and a well-respected resource of nationally respected investment knowledge. This spring, Tony Shipley represented the Angel Capital Association, a professional alliance of angel groups in the United States and Canada, in front of a Congressional subcommittee discussing equity finance as a catalyst for small business growth. The software entrepreneur, who founded the Cincinnati-based angel network, Queen City Angels= in 2000, testified about the financial and intellectual capital angel investors provide, while making suggestions on how Congress can use legislation and public policy to bolster the entrepreneurial ecosystem.

Shipley's presence at this meeting illustrates the growing national attention given to Midwest angels, who are making the region a hub for innovation. According to the 2011 HALO Report, 79 percent of angel group investments occurred outside of traditional funding mecca California. Of these investments, the Great Lakes region received the biggest proportion of them -- 15.9 percent, a percentage greater than the shares of innovation-rich regions such as New England and the Southeast.

MD Incubator

The 12th Annual Maryland Incubator Company of the Year Awards, supported by the Maryland Department of Business and Economic Development (DBED), the Maryland Technology Development Corporation (TEDCO), McGladrey, Inc. and Saul Ewing, is coming up.

The ceremony will recognize the achievement and potential among 18 current and graduate companies within Maryland's incubator network. Chris Brandenburg from Millennial Media, who received the 2008 information technology Incubator Company of the Year award, will be the keynote speaker. The event will also feature technology demonstrations by the finalist companies.

immunomic-therapeutics

Immunomic Therapeutics, Inc., ("ITI") a privately-held biotechnology company with laboratories in Rockville, MD, announced that it has been accepted to present at the Business Forum during the 2012 Bio International Convention. ITI's CEO, Bill Hearl, will present progress in internal development of LAMP-vax™ vaccines as well as opportunities for co-development.

JRC-LAMP-vax vaccine incorporates Immunomic Therapeutics' proprietary LAMP Technology™. LAMP (Lysosomal Associated Membrane Protein) is a normal and important component of the immune system that is present in the lysosome of all mammals. Incorporating LAMP Technology into vaccine design enables direct presentation of

immunomic-therapeutics

Immunomic Therapeutics, Inc., ("ITI," Lancaster, PA) a privately-held biotechnology company with laboratories in Rockville, MD, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug Application ("IND") filed for the allergy immunotherapy, JRC- LAMP-vax™.  On April 12th, the FDA notified ITI that there will be no clinical hold and that ITI may now proceed with its clinical trial in June for JRC-LAMP-vax in Atlanta with subjects sensitive to Japanese Red Cedar pollen.

JRC-LAMP-Vax is a plasmid-based DNA vaccine that will be studied for the treatment of patients with rhino-conjunctivitis (runny nose) symptoms caused by allergic reaction to Japanese red cedar pollen. Almost 45% of the Japanese people are allergic to Japanese red cedar pollen. In North America, there is allergic rhinitis to mountain cedar pollen, which is 80% cross-reactive with Japanese red cedar pollen allergen.  ITI intends to partner with a Japanese pharmaceutical company for studies in Japan and will seek FDA approval of the vaccine in the US.

Pharma Dollars

Counter-intuitive as it may be, investing in areas that pharma is abandoning could yield great returns for investors. Just look at anti-bacterials in the ’90s and 2000s, says VC Bruce Booth in a Forbes column. So where should investors be looking today? Neuroscience, heart failure and obesity.

The shortage of cancer drugs that’s plagued hospitals for almost two years now has eased, although not completely, according to cancer doctors.

A recent study by Johns Hopkins researchers brings a reality check to the potential (and the limits) of genome sequencing in predicting disease.

ninds-logo

I would like to bring to your attention that the Office of Translational Research (OTR) at the National Institute of Neurological Disorders & Stroke (NINDS) is seeking to fill two senior program leadership positions in neuroscience drug and device development. The two position descriptions are described briefly below and more detailed job descriptions are attached. Please forward this announcement to qualified candidates. We will be at the Biotechnology Industry Organization (BIO) meeting in Boston next week, and would be happy to meet to discuss these positions. To meet at BIO or for more information please contact Dr. Eric Nelson (This email address is being protected from spambots. You need JavaScript enabled to view it.) in OTR.

germs-map

Today, in two of the world’s top medical journals, scientists are publishing the results of a $173 million government-funded project to sequence the vast bulk of bacteria, fungi, and viruses in and on the human body.

The results might at first seem anticlimactic. There’s no news about which germs cause or prevent disease, or even a clear message about how they make people different from one another. What we know is there are a lot of them. We have ten times as many microbial cells in our body as human ones, and though they are tiny, that still means that a 200-pound man is carrying two to six pounds of microbes, mostly bacteria. And there are tantalizing hints that they might play a role in all sorts of diseases. Patients who are at risk for difficult-to-treat hospital infections might have a particular kind of bacteria in their digestive systems; those who are obese might have another; children who can’t get enough nutrition might have a third.

financial-coi

Advances in medical and surgical care are hard-won. They require rigorous, carefully interpreted laboratory research. Equally important is the painstaking clinical work to translate basic discoveries into useful diagnostics, drugs, and devices.  Despite the odds, the achievements made in the past half century are unmistakable: a 50 percent reduction in cardiovascular mortality despite an epidemic of obesity; a dramatically decreased cancer mortality rate; and the conversion of AIDS from a death sentence to survival with good life quality.

The key to such success has been the growing number and complexity of collaborations between academics, physicians, regulatory agencies, and—not least—industry. Unfortunately, over the past 20 years, a mania has taken hold that discounts the social value of collaboration and has mounted an inquisition against it, encapsulated by the epithet “financial conflict of interest (fCOI).” Critics’ unwarranted allegations that such conflicts cause bias have limited the sources of intellect that can contribute to a given project.

CMS

In a strong show of support for more effective, more affordable, higher quality health care, 45 commercial, federal and State insurers in seven markets today pledged to work with the Centers for Medicare & Medicaid Services (CMS) to give more Americans access to quality health care at lower cost.

Under the Comprehensive Primary Care initiative, CMS will pay primary care practices a care management fee, initially set at an average of $20 per beneficiary per month, to support enhanced, coordinated services.  Simultaneously, participating commercial, State, and other federal insurance plans are also offering an enhanced payment to primary care practices that provide high-quality primary care.  

SBIR STTR

The National Cancer Institute (NCI) recently announced a new Program Announcement, aimed at accelerating the development and commercialization of consumer health information technology products that translate the behavioral and communication science evidence base for the prevention and control of cancer and other chronic diseases. The NCI and the National Library of Medicine (a co-funding partner) are interested in supporting the development and dissemination of evidence-based health information technology (health IT) products that have the potential to:

  • Prevent or reduce the risk of cancer 
  • Facilitate patient-provider communication and/or 
  • Improve disease outcomes in consumer and clinical settings

A non-exclusive list of product examples relevant to the FOA are provided below.

DHHS

The Department of Health and Human Services (HHS), along with the Institute of Medicine (IoM) and other members of the Health Data Consortium, are co-hosting the third annual “Datapalooza” focusing on innovative applications and services that harness the power of open data from HHS and other sources to help improve health and health care.

The Health Data Initiative Forum III is featuring more than 100 new or updated solutions, up from 45 solutions last year, that help serve the needs of consumers, health care providers, employers, public health leaders, and policy makers.

“The innovators present today are a great example of how data and technology can be used in powerful ways to help consumers and providers improve health,” said HHS Secretary Kathleen Sebelius. “We’re not just creating new technology, but we’re empowering Americans to make better decisions about health and health care by putting information at their fingertips.”

Techcouncilmd

The Tech Council of Maryland (TCM), Maryland's largest technology trade association with more than 400 biotechnology and technology members employing more than 200,000 in the region, announced that it has moved into a new headquarters at 9210 Corporate Blvd., Suite 470 in Rockville, a short distance from its previous offices on Key West Ave. All phone numbers and e-mail addresses for TCM staff remain the same.

"The move to Corporate Blvd. accomplishes several things for the association," said Art Jacoby, TCM's CEO. "The space offers us a far better layout, which enables improved internal teaming, communication and productivity. And, it's 'right-sized,' so we're achieving some operating expense savings, as well. The staff and I are very excited and see this move as a fresh start the plans we have to strengthen TCM in the future."